Clinical Trial: Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

Brief Summary: Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem cells derived from the patient's adipose tissue. The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of transplantation of a single dose of autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into laminas for subjects with corneal defects. 3 groups will be included in the study: (1) transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)

Detailed Summary:

Different types of stem cells have been used in various ways in several research projects in order to find the optimal procedure to regenerate the human corneal stroma. It included several approaches which can be classified as intrastromal implantation of stem cells (1) alone, (2) together with a biodegradable scaffold, (3) with a non-biodegradable scaffold, or (4) with a decellularized corneal stromal scaffold. In fact, the complex structure of the corneal stroma has not been yet replicated, and there are well known drawbacks to the use of synthetic scaffold-based designs. Recently, several corneal decellularization techniques have been described, which provide an acellular corneal extracellular matrix (ECM). These scaffolds have gained attention in the last few years as they provide a more natural environment for the growth and differentiation of cells when compared with synthetic scaffolds. In addition, components of the ECM are generally conserved among species and are tolerated well even by xenogeneic recipients. Keratocytes are essential for remodeling the corneal stroma and for normal epithelial physiology. This highlights the importance of transplanting a cellular substitute together with the structural support (acellular ECM) to undertake these critical functions in corneal homeostasis. To the best of the investigators knowledge, all attempts to repopulate decellularized corneal scaffolds have used corneal cells, but these cells have major drawbacks that preclude their autologous use in clinical practice (damage of the donor tissue, lack of cells and inefficient cell subcultures), thus the efforts to find an extraocular source of autologous cells. A recent study by the investigators has shown a perfect biointegration of human decellularized corneal stromal sheets (100µm thickness) with and without h-ADASC colonization inside the rabbit cornea in vivo, without observing any rejection response despite the gra
Sponsor: Vissum, Instituto Oftalmológico de Alicante

Current Primary Outcome: Vision recovery (Corrected Distance Visual Acuity) [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]

The Best Corrected Visual Acuity will be measured in each postoperative visit to control any important decrease relative to the surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Corneal Thickness [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit a measurement of corneal pachymetry of the transplanted cornea will be carried out to detect any abnormal evolution
  • Topopgraphy [ Time Frame: post operative visit at 1 month, 3 months and 6 months ]
    At each post operative visit a measurement of Anterior surface topography of the transplanted cornea will be carried out to detect any abnormal evolution
  • Anterior segment Optical Coherence Tomography [ Time Frame: post operative visit at 1 month, 3 months and 6 months ]
    At each post operative visit a measurement anterior segment Optical Coherence Tomography of the transplanted cornea will be carried out to detect any abnormal evolution
  • Slit Lamp Observation [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit, the corneal aspect relative to new tissue will be evaluated by slit lamp observation
  • refraction measurement [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit, the corneal aspect relative to increase in irregular astigmatism will be evaluated by refraction measurement


Original Secondary Outcome: Same as current

Information By: Vissum, Instituto Oftalmológico de Alicante

Dates:
Date Received: October 2, 2016
Date Started: November 2015
Date Completion:
Last Updated: October 11, 2016
Last Verified: October 2016